Validation of HPLC Method for Quantitative Determination of Gefitinib in Polymeric Nanoformulation
- Authors: KS N.S.1, K G.P.1, Verma R.2, Ananthakrishna P.3, Kumar L.1
-
Affiliations:
- Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University
- Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical Sciences, Manipal University
- Head-Third Party Quality, Cipla Limited
- Issue: Vol 51, No 2 (2017)
- Pages: 159-163
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244522
- DOI: https://doi.org/10.1007/s11094-017-1575-6
- ID: 244522
Cite item
Abstract
Gefitinib was determined quantitatively in a nanoformulation using the proposed HPLC method. Effective elution was achieved by using a stationary phase of HyperClone (Phenomenex®) C18 column (250 mm × 4.6 mm i.d., 5 μm, BDS 130 Å) and a mobile phase composed of acetonitrile and 40 mM ammonium formate buffer pH 2.5 (30 : 70, %v/v) at a flow rate of 1.0 mL/min. The samples were measured at 248 nm using UV detector. The column temperature was kept at 25°C; the run time was 7 min; the injection volume was 20 μL. Gefitinib was separated within 4.476 min. The correlation coefficient for the obtained calibration curve was found to be 0.998. The method was validated according to ICH Q2 (R1) guidelines for linearity, sensitivity, robustness, accuracy and precision. The LOD and LOQ were found to be 37.852 and 114.702 ng/mL, respectively.
About the authors
Navya Sree KS
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University
Email: lk.kundlas@gmail.com
India, Madhav Nagar, Manipal, Udupi, Karnataka, 576104
Girish Pai K
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University
Email: lk.kundlas@gmail.com
India, Madhav Nagar, Manipal, Udupi, Karnataka, 576104
Ruchi Verma
Department of Pharmaceutical Chemistry, Manipal College of Pharmaceutical Sciences, Manipal University
Email: lk.kundlas@gmail.com
India, Madhav Nagar, Manipal, Udupi, Karnataka, 576104
Padiyar Ananthakrishna
Head-Third Party Quality, Cipla Limited
Email: lk.kundlas@gmail.com
India, Mumbai, Maharashtra, 400083
Lalit Kumar
Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University
Author for correspondence.
Email: lk.kundlas@gmail.com
India, Madhav Nagar, Manipal, Udupi, Karnataka, 576104